Adult clinical trial participation

Definition: The ratio of the total number of all patients aged 19 years or older newly enrolled in cancer-related therapeutic trials or clinical research studies to the projected number of new incident cancer cases

Rationale for measurement: Patients who are treated in cancer centres with active clinical trial programs tend to have better health outcomes than those treated in centres that do not participate in clinical trials. This finding is likely due to better processes and delivery of care, including treatment guideline concordance. Although the number of cancer clinical trials opened per year remained the same or grew from 2000 to 2010, patient enrolment per year has plateaued or decreased. Comparing clinical trial participation across the country can identify opportunities for action.

Measurement timeframe: Years 2012 to 2015

Denominator:

• For year 2012 – 2014: All new cancer incidence cases with age ≥ 19
• For year 2015: Projected number of new invasive cancer cases with age ≥ 19

Numerator: Number of cancer patients (≥19 years) newly enrolled in cancer-related therapeutic clinical trials or clinical research at provincial cancer centers.

Exclusion criteria:

1. Patient age ≤ 18 were excluded
2. In-situ cancers except in-situ bladder cancer were excluded

Data availability: BC, AB, SK, MB, ON, NB, PE and NL

Stratification:

1. By year
2. By province

Data source: Provincial cancer agencies and programs; Canadian Cancer Society, Canadian Cancer Statistics; Statistics Canada, Canadian Cancer Registry

Data retrieval date: October 2017

Variables details:

For cancer cases:

1. Cancer cases include all invasive cancer cases and In situ bladder cancer cases.

For patients enrolled in clinical trials:

2. Cancers related to the patients enrolled in clinical trial include all invasive cancers and in-situ bladder cancer (to ensure consistency with Canadian Cancer Statistics).
3. For patient enrolled in multiple clinical trials, all occurrences were counted.

Notes from jurisdictions:

• AB: To be consistent with data previously submitted from other years, Indicator 1d includes the total number of accruals for cancer patients (>=19 years) newly enrolled in cancer related therapeutic trials or clinical research in 2012-2015 who were on the Alberta Cancer Clinical Trials (ACCT) database. If a patient went on multiple clinical trial accruals in the given year, a patient would be counted for each accrual. The ACCT database also includes patients who were living outside of Alberta, as long as they were on a clinical trial in Alberta. The ACCT database includes both females and males in the Breast Tumour Group. The ACCT database may include clinical trials for non-melanoma skin patients.
• MB: We can exclude out of province patients treated in Manitoba if necessary. This would result in a decrease of 1 patient in the GU group.
• ON: The Ontario recruitment numerator also included biomarker studies IF the results were directing patient management. Cancer-specific numbers not available. The numerator includes the number of cancer patients (≥18 years) newly enrolled in cancer-related therapeutic clinical trials or clinical research at provincial cancer centres. Ontario does not report in situ bladder cancer
• NS: Nova Scotia will not be providing these data this time around. There has always been a suspicion that the numbers underrepresented the true number of Nova Scotia cancer patients enrolled in clinical trials, since the data are not centralized. The Nova Scotia health system has recently been restructured, staff have changed, and clinical trial processes are being stream-lined. Nova Scotia will provide these numbers in the future once we have confidence that the numbers accurately represent accrual activity across the province.

Methodology notes:

1. Data for newly enrolled in cancer-related therapeutic clinical trials or clinical research were provided by pprovincial cancer agencies and programs. Data for cancer incidence cases were retrieved from Canadian Cancer Statistics.
2. Due to availability, the number of cancer incidence cases for years 2012 to 2014 were actual; while for year 2015 it was projected from Canadian Cancer Statistics.
3. Data for the cancer incidence cases were re-estimated to the age ≥ 19, correspondingly to the ages for the newly enrolled in cancer-related therapeutic clinical trials or clinical research.
4. Data presented include all invasive cancer cases and in-situ bladder cancer cases.

Changes to definition compared to previous years: No applicable